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Risk Assessment

Introduction to Environmental Health Fall 2011

Risk Assessment in Environmental Health

A process employed to estimate the potential for selected health effects that may be caused by exposure to toxicants in the environment !ay be used assess the risk of health effects from actual" potential" or theoretical exposure Risk assessment is a modelin# process that relies on a number of assumptions and !odel output cannot be more precise or accurate than the input data $hus" understandin# the assumptions and input data is essential to interpret and explain the results

&hat is Risk'

Risk ( the likelihood or probability of an adverse event or outcome $he concept of risk is utili)ed in many fields includin# finance" insurance en#ineerin# etc Health Risk * likelihood of an adverse health effect or illness Risk may be expressed either +uantitatively or +ualitatively $he expressions used vary by application

,ualitative * -.ittle or no risk/ ,uantitative * 0ompare dose or exposure concentration 1ith appropriate reference value

Risk Assessment3 4asic 5aradi#m

Risk is proportional to Ha)ard x Exposure

Ha)ard is a property of the substance bein# studied

Is it toxic' Ho1 toxic' Is it in a form 6 location that 1e come in contact 1ith'

i e A lead fishin# sinker is less ha)ardous than lead dust or fume in most circumstances

Exposure is the extent to 1hich 1e are in contact 1ith the ha)ard

&hat environmental media' 7Air" &ater" 8oil" Food etc9 0oncentration of the substance in that media Route of exposure :uration of exposure

-All $hin#s 0onsidered/

Why is it being conducted? What questions need to be answered? Who is affected? What is known about the health effects and dose-response relationship of the substance? What are the important exposure pathways and what is the expected contaminant concentration in these media? How will the result be used?

How much uncertainty is acceptable?

; 8ource3 A$8:R< 5ublic Health Assessment =uidance !anual

$he 2<8tep Risk Assessment 5rocess

Ha)ard Identification Exposure Assessment :ose<Response Assessment?
? a k a $oxicity Assessment

Risk 0haracteri)ation

Hazard Identification
0haracteristics of the Ha)ardous 8ubstance

A description of the potential health effects attributable to a specific chemical or physical a#ent 0onsider physical properties and -transformation/ of the substance

5hysical state" 8olubility" Aapor 5ressure" 4indin# capacity

0onsider fate" transport and transformation in the environment

!obility * 8oil&aterAir etc 4ioaccumulation $ransformation i e H#methylmercury

&hat are the adverse effects' !ost relevant and sensitive' Irritation" Br#an<specific $oxicity" 0ancer etc

:ose<Response Assessment

$he determination of the relationship bet1een the ma#nitude of administered" applied" or internal dose and a specific biolo#ical response Response can be expressed as measured or observed incidence" percent response in #roups of subDects 7or populations9" or the probability of occurrence of a response in a population If there are multiple health effects 7toxicolo#ic endpoints9" determine 1hich -non<trivial/ effect occurs at the lo1est dose 8ufficient data to support a dose<response relationship is not al1ays present for human exposure" especially for non< occupational exposure to -lo1<level/ environmental contaminants 0omparison values developed by various a#ency are a product of the dose<response assessment $hey may be appropriate to specific assessments and are typically intended to ensure that risk is not underestimated

Source: US !"

Fse of 0omparison Aalues in :ose< Response Assessment

For carcino#enic effect3 0ancer 8lope Factor Inhalation Fnit Risk Factor Gon<carcino#enic effects3 !inimal Risk .evel or !R. Reference :ose or Rf: Reference 0oncentration or Rf0 !any others !edia specific -screenin# levels/ or standards 4rief or emer#ency exposures 7ER5=" AE=.9

:erivation of comparison values

4enchmark A dose associated 1ith a specified lo1 level of risk 7e # ;H" 10H etc 9 GBAE. 7Go Bbserved Adverse Effect .evel9 Hi#hest dose level 7belo1 the .BAE.9 at 1hich no adverse or toxic effect has been observed .BAE. 7.o1est Bbserved Adverse Effect .evel9 $he lo1est dose level at 1hich an adverse or toxic effect has been observed

Fncertainty factors used in determinin# comparison values

Fncertainty Factors 7FF9 are applied to assure the comparison value is protective :efault FFs vary 1ithin and amon# a#encies AdDustments are multiplied If a FF of 10 1ere applied for each of three reasons to a .BAE." the resultant comparison value 1ould be 1I1000th of the .BAE.


Basis for adjustment


Fnderstandin# the assumptions

$he Rf: and Rf0 are intended to provide an estimate of a daily exposure to the human population includin# sensitive sub#roups that is likely to be 1ithout an appreciable risk of deleterious effects durin# a lifetime 7@0 yrs9 0ancer slope factors and inhalation unit risk factors are intended too provide a means to estimate a theoretical risk of one excess cancer in a population of 1 million over a lifetime of exposure AE=.s 7Acute Exposure =uideline .evels9 are intended to estimate the risk of acute health effects resultin# from exposures ran#in# from 10 minutes to C hours GJ 8oil 0leanup 0riteria assumptions for non<carcino#ens

Residential3 Gon<residential3

EF %;0 days" E: > yrsK 4& 1; k#K IR 200 m#Iday EF 22; days" E: 2; yrsK 4& @0 k#K IR 100 #Iday


-0omparin# comparison values/

0omparison values for a substance are derived based upon a specific health effect and are sometimes specific to a route of exposure 0omparison values may differ amon# and sometimes 1ithin a#encies for the same substance" health effect and route of exposure Aariation in uncertainty factors :ifferent studies form the basis of the dose<response determination Assumptions re#ardin# exposure differ Assure a comparison value is appropriate to your assessment and evaluation !ore than one value may be used $here is no sin#le source of -the correct/ comparison values All are estimates based on assumptions and research" both of 1hich are subDect to chan#e 8electin# the -ri#ht/ comparison values re+uires an understandin# of the assumptions an data


!ultiple 0omparison Aalues Example3 !ercury Aapor 7u#Im%9

&orkers B8HA 5E. GIB8H RE. A0=IH $&A 2; 0 100 0 ;0 0 0hronic population exposure E5A Rf0 0% A$8:R !R. 0al<BEHHA RE. 0 0E 02

Acute population exposure E5A 1hr<AE=.%? 2"200 0 E5A 1hr<AE=.2? %%% 0 0al<BEHHA RE. 1C

Bther advisory values?? Isolate persons from exposure 10 0 5ost<remediation re<occupancy 1 0

??A$8:R and others

? see belo1 AEGL3 < the airborne concentration of a substance above 1hich it is predicted that the #eneral population" includin# susceptible individuals" could experience life<threatenin# health effects or death AEGL2 < L irreversible or other serious" lon#<lastin# adverse health effects or an impaired ability to escape 8ource3 http3IIepa #ovIopptIae#lIpubsIdefine htm

Exposure Assessment

Exposure < contact bet1een a human and a contaminant It is influenced by many factors includin#3

0oncentration of a contaminant in environmental media Ho1 much' &hat media' $he manner and extent of an individualMs contact 1ith that media &hat route' Ho1 often' Ho1 lon#' Ho1 much'


Exposure !easurement

!easure the concentration of a contaminant in an environmental media and estimate or measure the an individualMs contact 1ith that media and inte#rate these to develop the exposure estimate or dose !easure substances 7biomarkers9 that are indicative of exposure or effect in human biolo#ical media 7tissues" hair" blood" urine" feces" breath etc 9

the toxicant itself its metabolite substances formed by the body in response to the toxicant

:irect Exposure !easurement < 4iomarkers

Exo#enous chemicals" their metabolites" or products of interactions bet1een a xenobiotic chemical and some tar#et molecule or cell that is measured in a compartment 1ithin an or#anism $ypically reflect internal exposure from all path1ays and sources 5rovide individuali)ed exposure measurements 0onsiderations3

Aalidity of the marker for its intended use Invasiveness of the samplin# method 5racticality of the samplin# method 7e # 22<hr urine specimen9 .e#al re+uirements

Informed consent 5rivacy rules


4iomonitorin#3 5opulation -norms/

It may not be -normal/ to have toxicants in our body ho1ever most of us do 0:0 and others are conductin# on#oin# assessments human exposure throu#h biomonitorn#
12 B$ood H% &u%'L( 10
)o fis* mea$ fis*mea$s 1+2 fis*mea$s ,3

6 4 2 0 0 2! !0 "! 100 #ercenti$e

http3II111 cdc #ovIexposurereportI


Indirect Exposure !easurement

0oncentration of the contaminant in environmental media 8ample collection 7air" 1ater" soil" food9

Ho1' &here' &hen' Ho1 !any' &here' &hat methods'

8ample analysis

Extent of contact of individuals 1ith environmental media

:ependant on individual characteristics and activity patterns

Ho1 much air does a person breathe' Ho1 lon# is the person in the -contaminated/ environment' &hat is the person doin# 1hen they are in that environment'

Exposure factors are available to aid in these determinations


Exposure Factors

5hysical characteristics 4ody mass and surface area by a#e and #ender 0ontact rates Inhalation rates by a#e" #ender and activity level &ater consumption by a#e" #ender" activity level and climate Food in#estion by type" locale" etc Activity patterns Hours spent at home" in car" etc by a#e and #ender Activity level by a#e" #ender" etc 8ho1er and bath fre+uency and duration !any others 8oil in#estion 8oil adherence to skin
-.U/0 /EE1 2eferences Exposure Factors Handbook " F 8 E5A Child-Specific Exposure Factors Handbook, " F 8 E5A Available3 http3IIcfpub epa #ovInceaIcfmIefpro# cfm21

Exposure Factors * :efault Assumptions

All factors are estimates Fsin# factors more specific to the population or circumstances 1ill help refine the estimate For example" use #ender or a#e specific factors if you have the data to support it :efault assumptions are used 1here insufficient data exists and also for purposes of screenin# Adults @0 k#

4ody1ei#ht Inhalation :rinkin# 1ater

0hildren 1> k# 71<> y o9 C @ m%Iday 71<12 y o 9 1 .Iday


1; 2 m%Iday 2 .Iday

female 11 % m%Iday

Estimatin# :aily Intake

:I ( 70 x IR9 I 4&
&here3 :I ( :aily intake 7m#Ik#9

0 ( 0oncentration in environmental medium 7m#Ik#" m#I." m#Im%9 IR ( Intake rate of the environmental medium 7k#Iday" .Iday" m%Iday9 4& ( 4ody 1ei#ht 7kilo#rams9

For multimedia exposure3 N70 x IR 9air O 70 x IR9LP I 4&


Inte#rate environmental and individual data

$he exposure estimate inte#rates information re#ardin# environmental contamination and individual factors that determine their contact 1ith the contaminant
A3 0ontaminant 5ersonal measurement !easurement in media proximal to the points of exposure Extrapolation of measurements media else1here to the point of exposure Extrapolation based on little or no site specific information 43 Individual !easure or direct observation 8elf<reports" activity lo#s" records Fse -refined/ reference values incorporatin# some specific information Fse -default/ reference values

Risk 0haracteri)ation

$he results of the Exposure Assessment and :ose<Response Assessment are summari)ed and inte#rated into +uantitative and +ualitative expressions of risk For non<carcino#enic effects" comparisons are made bet1een proDected intakes of substances and comparison values $he numeric expression of this comparison is often called the Ha)ard ,uotient 0arcino#enic effects are typically expressed as a probability of developin# cancer assumin# a lifetime of exposure Risk characteri)ation includes +ualitative and +uantitative expressions of risk and must also include explanation and interpretation of the risk in li#ht of the assumptions" Dud#ments" and uncertainty inherent in the process


Ha)ard Index 7HI9 $he sum of more than one ha)ard +uotient for multiple substances andIor multiple exposure path1ays $he HI is calculated separately for chronic" subchronic" and shorter<duration exposures Ha)ard ,uotient $he ratio of a sin#le substance exposure level over a specified time period 7e # " subchronic9 to a reference dose for that substance derived from a similar exposure period 8lope Factor A plausible upper<bound estimate of the probability of a response per unit intake of a chemical over a lifetime $he slope factor is used to estimate an upper<bound probability of an individual developin# cancer as a result of a lifetime of exposure to a particular level of a potential carcino#en

Gumeric estimates of risk

Gon<carcino#ens * Ha)ard Index 7HI9" Ha)ard ,uotient 7H,9

:ivide daily intake by comparison value 7Rf:" Rf0" !R.9

Aalue Q 1 ( no appreciable risk

0arcino#ens * Excess risk of developin# cancer

!ultiply :I by cancer slope factor 708F9 or unit risk factor 7FRF9

Aalue ( additional cancers per number of individuals exposed 7e # 0 00001 ( a risk of 1 additional person per amon# 100"000 population developin# cancer over a lifetime9

Example3 ,uick screenin# scenario

Assume persons 1ei#hin# @0 k# consume 2 .Iday of drinkin# 1ater containin# ;0 u#Il arsenic I#nore other routes or sources of exposure &hat is the daily intake of arsenic from this exposure' 7:I9 ( 70 x IR9 R 4& :I ( 70 0; m#I. x 2 .Id9 R @0 k# ( 0 0012 m#Ik#<d &hat is the non<cancer risk estimate of this exposure' 0omparison value 7e # E5A Bral Rf: ( 0 000% m#Ik#<d9 Ha)ard Index ( :I R Rf: Ha)ard index ( 0 0012 m#Ik#<day R 0 000% m#Ik#<d ( 2 @ &hat is the cancer risk estimate for this exposure' 0omparison value 7e # E5A Bral 08F ( 1 ; 7for :I in m#Ik#<d9 Excess cancer risk ( :I S 08F Excess cancer risk ( 0 0012 m#Ik#<day x 1 ; ( 0 002
7e # 2 excess cancers per 1"000 people consumin# this 1ater over a lifetime9


8imply bein# exposed to a ha)ardous substance does not make it a health risk $he ma#nitude" fre+uency" timin#" and duration of exposure and the toxicity characteristics of individual substances affect the de#ree of risk" if any


Ho1 much risk is acceptable'

:epends on the context and 1ho you ask Ha)ard +uotient + A comparison of an estimated chemical intake 7dose9
1ith a reference dose level belo1 1hich adverse health effects are unlikely 0onservatively Q 1 is #ood

-:e minimis riskT refers to a level of risk 1hich is too small to be

concerned 1ith << some refer to this as a Tvirtually safeT level For cancer risk" an increase of 1 in 1"000"000 or lo1er is considered de minimis